Archive | Regulatory

Melanoma Research Alliance Hails FDA’s First ‘Triplet’ Combination Approval for Melanoma

The Melanoma Research Alliance (MRA), the largest non-profit funder of melanoma research worldwide, welcomes the decision by the U.S. Food and Drug Administration (FDA) approving Genentech’s Tecentriq ® (atezolizumab) plus Cotellic ® (cobimetinib) and Zelboraf ® (vemurafenib) for the treatment of BRAF V600 mutation-positive advanced melanoma patients.

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Posted in Melanoma News, Regulatory, Publications

FDA Grants Fast Track Designation to CMP-001 Combination in Advanced Melanoma

The FDA has granted Fast Track designation to CMP-001 in combination with nivolumab (Opdivo) plus ipilimumab (Yervoy), which will undergo clinical trial development both as a potential extender of time to disease relapse as an initial treatment of patients with unresectable stage III or stage IV melanoma, as well as to improve the overall tumor […]

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Posted in Melanoma News, Regulatory, Publications

Polynoma Receives FDA Fast Track Designation for its Melanoma Cancer Vaccine Seviprotimut-L

Polynoma LLC, announces that the U.S. Food and Drug Administration (FDA) has granted its application for Fast Track designation of seviprotimut-L.

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Posted in Melanoma News, Regulatory, Publications

NKTR-214 with Opdivo Earns FDA’s Breakthrough Therapy Designation for Advanced Melanoma

The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation for a combination of the potential therapy NKTR-214 with Opdivo (nivolumab) for untreated melanoma patients with either metastatic disease or who are unable to undergo surgery.

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Posted in Melanoma News, Regulatory, Publications